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Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 1
ENDOCRINE PRACTICE Vol 21 No. 4 April 2015
American Association of Clinical Endocrinologists and
American College of Endocrinology Clinical Practice Guidelines for Developing a Diabetes Mellitus
Comprehensive Care PlanWriting Committee Cochairpersons
Yehuda Handelsman MD, FACP, FACE, FNLAZachary T. Bloomgarden, MD, MACEGeorge Grunberger, MD, FACP, FACE
Guillermo Umpierrez, MD, FACP, FACERobert S. Zimmerman, MD, FACE
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 2
AACE Clinical Practice Guidelines for Diabetes Mellitus Writing Committee Task ForceTimothy S. Bailey, MD, FACP, FACE, ECNULawrence Blonde MD, FACP, FACEGeorge A. Bray, MD, MACP, MACEA. Jay Cohen MD, FACE, FAAPSamuel Dagogo-Jack, MD, DM, FRCP, FACEJaime A. Davidson, MD, FACP, MACEDaniel Einhorn, MD, FACP, FACEOm P. Ganda, MD, FACEAlan J. Garber, MD, PhD, FACEW. Timothy Garvey, MDRobert R. Henry, MDIrl B. Hirsch, MDEdward S. Horton, MD, FACP, FACEDaniel L. Hurley, MD, FACEPaul S. Jellinger, MD, MACELois Jovanovič, MD, MACE
Harold E. Lebovitz, MD, FACEDerek LeRoith, MD, PhD, FACEPhilip Levy, MD, MACEJanet B. McGill, MD, MA, FACEJeffrey I. Mechanick, MD, FACP, FACE, FACN, ECNUJorge H. Mestman, MDEtie S. Moghissi, MD, FACP, FACEEric A. Orzeck, MD, FACP, FACEPaul D. Rosenblit, MD, PhD, FACE, FNLAAaron I. Vinik, MD, PhD, FCP, MACP, FACEKathleen Wyne, MD, PhD, FNLA, FACEFarhad Zangeneh, MD, FACP, FACE ReviewersLawrence Blonde MD, FACP, FACEAlan J. Garber, MD, PhD, FACE
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 3
AACE DM CPG Objectives and StructureThis CPG aims to provide the following:
An evidence-based education resource for the development of a diabetes comprehensive care plan
Easy-to-follow structure 24 diabetes management questions 67 practical recommendations
Concise, practical format that complements existing DM textbooks
A document suitable for electronic implementation to assist with clinical decision-making for patients with DM
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 4
AACE DM CPGEvidence Ratings and GradesEvidence
levelEvidence
grade Semantic descriptor
1 A Meta-analysis of randomized controlled trials (MRCT)
1 A Randomized controlled trials (RCT)
2 B Meta-analysis of nonrandomized prospective or case-controlled trials (MNRCT)
2 B Nonrandomized controlled trial (NRCT)
2 B Prospective cohort study (PCS)
2 B Retrospective case-control study (RCCS)
3 C Cross-sectional study (CSS)
3 CSurveillance study (registries, surveys, epidemiologic study, retrospective chart review, mathematical modeling of database) (SS)
3 C Consecutive case series (CCS)
3 C Single case reports (SCR)
4 D No evidence (theory, opinion, consensus, review, or preclinical study) (NE)
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 5
AACE DM CPG Questions1. How is diabetes screened and
diagnosed?2. How is prediabetes managed?3. What are glycemic treatment
goals of DM?4. How are glycemic targets
achieved for T2D?5. How should glycemia in T1D be
managed?6. How is hypoglycemia managed?7. How is hypertension managed in
patients with diabetes?
8. How is dyslipidemia managed in patients with diabetes?
9. How is nephropathy managed in patients with diabetes?
10. How is retinopathy managed in patients with diabetes?
11. How is neuropathy diagnosed and managed in patients with diabetes?
12. How is CVD managed in patients with diabetes?
13. How is obesity managed in patients with diabetes?
Continued on next slide
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AACE DM CPG Questions14. What is the role of sleep medicine
in the care of the patient with diabetes?
15. How is diabetes managed in the hospital?
16. How is a comprehensive diabetes care plan established in children and adolescents?
17. How should diabetes in pregnancy be managed?
18. When and how should glucose monitoring be used?
19. When and how should insulin pump therapy be used?
20. What is the imperative for education and team approach in DM management?
21. What vaccinations should be given to patients with diabetes?
22. How should depression be managed in the context of diabetes?
23. What is the association between diabetes and cancer?
24. Which occupations have specific diabetes management requirements?
Continued from previous slide
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• Age ≥45 years without other risk factors
• Family history of T2D• CVD• Overweight
• BMI ≥30 kg/m2
• BMI 25-29.9 kg/m2 plus other risk factors*
• Sedentary lifestyle • Member of an at-risk racial or ethnic
group: Asian, African American, Hispanic, Native American, and Pacific Islander
• Dyslipidemia• HDL-C <35 mg/dL• Triglycerides >250 mg/dL
• IGT, IFG, and/or metabolic syndrome• PCOS, acanthosis nigricans, NAFLD• Hypertension (BP >140/90 mm Hg or
therapy for hypertension)• History of gestational diabetes or
delivery of a baby weighing more than 4 kg (9 lb)
• Antipsychotic therapy for schizophrenia and/or severe bipolar disease
• Chronic glucocorticoid exposure• Sleep disorders† in the presence of
glucose intolerance• Screen at-risk individuals with glucose values in the normal range every 3 years• Consider annual screening for patients with 2 or more risk factors
Criteria for Screening for T2D and Prediabetes in Asymptomatic Adults
*At-risk BMI may be lower in some ethnic groups; consider using waist circumference.†Obstructive sleep apnea, chronic sleep deprivation, and night shift occupations.BMI = body mass index; BP = blood pressure; CVD=cardiovascular disease; HDL-C = high density lipoprotein cholesterol; IFG = impaired fasting glucose; IGT = impaired glucose tolerance; NAFLD = nonalcoholic fatty liver disease; PCOS = polycystic ovary syndrome; T2D, type 2 diabetes.
Q1. How is diabetes screened and diagnosed?
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 8
Diagnostic Criteria for Prediabetes and Diabetes in Nonpregnant Adults
Normal High Risk for Diabetes DiabetesFPG <100 mg/dL IFG
FPG ≥100-125 mg/dL FPG ≥126 mg/dL
2-h PG <140 mg/dL IGT2-h PG ≥140-199 mg/dL
2-h PG ≥200 mg/dLRandom PG ≥200 mg/dL + symptoms*
A1C <5.5%5.5 to 6.4%For screening of prediabetes†
≥6.5%Secondary‡
*Polydipsia (frequent thirst), polyuria (frequent urination), polyphagia (extreme hunger), blurred vision, weakness, unexplained weight loss.†A1C should be used only for screening prediabetes. The diagnosis of prediabetes, which may manifest as either IFG or IGT, should be confirmed with glucose testing.‡Glucose criteria are preferred for the diagnosis of DM. In all cases, the diagnosis should be confirmed on a separate day by repeating the glucose or A1C testing. When A1C is used for diagnosis, follow-up glucose testing should be done when possible to help manage DM.
FPG, fasting plasma glucose; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; PG, plasma glucose.
Q1. How is diabetes screened and diagnosed?
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Diagnostic Criteria for Gestational Diabetes
Test Screen at 24-28 weeks gestation
FPG, mg/dL >921-h PG*, mg/dL ≥180
2-h PG*, mg/dL ≥153
*Measured with an OGTT performed 2 hours after 75-g oral glucose load.
FPG, fasting plasma glucose; OGTT, oral glucose tolerance test; PG, plasma glucose.
Q1. How is diabetes screened and diagnosed?
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AACE. Endocrine Pract. 2010;16:155-156.
AACE Recommendations for A1C TestingA1C should be considered an additional
optional diagnostic criterion, not the primary criterion for diagnosis of diabetes
When feasible, AACE/ACE suggest using traditional glucose criteria for diagnosis of diabetes
A1C is not recommended for diagnosing type 1 diabetes
A1C is not recommended for diagnosing gestational diabetes
Q1. How is diabetes screened and diagnosed?
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AACE Recommendations for A1C TestingA1C levels may be misleading in several ethnic
populations (for example, African Americans)A1C may be misleading in some clinical settings
HemoglobinopathiesIron deficiencyHemolytic anemiasThalassemiasSpherocytosisSevere hepatic or renal disease
AACE/ACE endorse the use of only standardized, validated assays for A1C testing
AACE. Endocrine Pract. 2010;16:155-156.
Q1. How is diabetes screened and diagnosed?
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Diagnosing Type 1 Diabetes (T1D)Usually characterized by insulin deficiency and
dependencyDocument levels of insulin and C-peptide
Test for autoantibodies*InsulinGlutamic acid decarboxylasePancreatic islet cells (tyrosine phosphatase IA-
2)Zinc transporter (ZnT8)
May occur in overweight or obese as well as lean individuals
Q1. How is diabetes screened and diagnosed?
*Evidence of autoimmunity may be absent in idiopathic T1D.
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Series10
2
4
6
8
10
12
4.8
7.8
11
T2D Incidence in the DPP
Intensive lifestyle intervention*
(n=1079)
T2D
M in
cide
nce
per 1
00 p
erso
n-ye
ars
Placebo(n=1082)
Metformin850 mg BID
(n=1073)
58%
31%
*Goal: 7% reduction in baseline body weight through low-calorie, low-fat diet and ≥150 min/week moderate intensity exercise.
DPP, Diabetes Prevention Program; IGT, impaired glucose tolerance; T2D, type 2 diabetes.
DPP Research Group. N Engl J Med. 2002;346:393-403.
Q2. How is prediabetes managed?
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Medical and Surgical Interventions Shown to Delay or Prevent T2D
T2D, type 2 diabetes.
1. DPP Research Group. N Engl J Med. 2002;346:393-403. 2. STOP-NIDDM Trial Research Group. Lancet. 2002;359:2072-2077.3. Defronzo RA, et al. N Engl J Med. 2011;364:1104-15. 4. DREAM Trial Investigators. Lancet. 2006;368:1096-1105.5. Torgerson JS, et al. Diabetes Care. 2004;27:155-161. 6. Garvey WT, et al. Diabetes Care. 2014;37:912-921.7. Sjostrom L, et al. N Engl J Med. 2004;351:2683-2693.
Q2. How is prediabetes managed?
InterventionFollow-up
PeriodReduction in Risk of T2D
(P value vs placebo)Antihyperglycemic agents
Metformin1 2.8 years 31% (P<0.001)Acarbose2 3.3 years 25% (P=0.0015)Pioglitazone3 2.4 years 72% (P<0.001)Rosiglitazone4 3.0 years 60% (P<0.0001)
Weight loss interventions
Orlistat5 4 years 37% (P=0.0032)Phentermine/
topiramate6 2 years 79% (P<0.05)
Bariatric surgery7 10 years 75% (P<0.001)
Lifestyle modification should be used with all pharmacologic or surgical interventions.
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Outpatient Glucose Targets for Nonpregnant Adults
Parameter Treatment Goal
A1C, %
Individualize on the basis of age, comorbidities, duration of disease, and hypoglycemia risk:• In general, ≤6.5 for most*• Closer to normal for healthy• Less stringent for “less healthy”
FPG, mg/dL <110
2-Hour PPG, mg/dL <140
Q3. What are glycemic treatment goals of DM?
FPG = fasting plasma glucose; PPG = postprandial glucose.
*Provided target can be safely achieved.
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Outpatient Glucose Targets for Pregnant Women
Condition Treatment GoalGestational diabetes mellitus (GDM)
Preprandial glucose, mg/dL ≤95*
1-Hour PPG, mg/dL ≤140*
2-Hour PPG, mg/dL ≤120*
Preexisting T1D or T2DPremeal, bedtime, and overnight glucose, mg/dL 60-99*
Peak PPG, mg/dL 100-129*
A1C ≤6.0%*
FPG = fasting plasma glucose; PPG = postprandial glucose.
*Provided target can be safely achieved.
Q17. How should diabetes in pregnancy be managed?
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Inpatient Glucose Targets for Nonpregnant Adults
Hospital Unit Treatment GoalIntensive/critical care
Glucose range, mg/dL 140-180*
General medicine and surgery, non-ICU
Premeal glucose, mg/dL <140*Random glucose, mg/dL <180*
Q3. What are glycemic treatment goals of DM?
ICU = intensive care unit.
*Provided target can be safely achieved.
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Therapeutic Lifestyle ChangesParameter Treatment Goal
Weight loss(for overweight and obese patients)
Reduce by 5% to 10%
Physical activity 150 min/week of moderate-intensity exercise (eg, brisk walking) plus flexibility and strength training
Diet
• Eat regular meals and snacks; avoid fasting to lose weight
• Consume plant-based diet (high in fiber, low calories/glycemic index, and high in phytochemicals/antioxidants)
• Understand Nutrition Facts Label information• Incorporate beliefs and culture into discussions• Use mild cooking techniques instead of high-heat
cooking• Keep physician-patient discussions informal
Q4. How are glycemic targets achieved for T2D?
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Healthful Eating RecommendationsCarbohydrate
Specify healthful carbohydrates (fresh fruits and vegetables, legumes, whole grains); target 7-10 servings per dayPreferentially consume lower-glycemic index foods (glycemic index score <55 out of 100: multigrain bread, pumpernickel bread, whole oats, legumes, apple, lentils, chickpeas, mango, yams, brown rice)
Fat Specify healthful fats (low mercury/contaminant-containing nuts, avocado, certain plant oils, fish)Limit saturated fats (butter, fatty red meats, tropical plant oils, fast foods) and trans fat; choose fat-free or low-fat dairy products
Protein Consume protein in foods with low saturated fats (fish, egg whites, beans); there is no need to avoid animal proteinAvoid or limit processed meats
Micronutrients
Routine supplementation is not necessary; a healthful eating meal plan can generally provide sufficient micronutrientsChromium; vanadium; magnesium; vitamins A, C, and E; and CoQ10 are not recommended for glycemic controlVitamin supplements should be recommended to patients at risk of insufficiency or deficiency
Q4. How are glycemic targets achieved for T2D?
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 21
Healthful Eating RecommendationsCarbohydrate
Specify healthful carbohydrates (fresh fruits and vegetables, legumes, whole grains); target 7-10 servings per dayPreferentially consume lower-glycemic index foods (glycemic index score <55 out of 100: multigrain bread, pumpernickel bread, whole oats, legumes, apple, lentils, chickpeas, mango, yams, brown rice)
Fat Specify healthful fats (low mercury/contaminant-containing nuts, avocado, certain plant oils, fish)Limit saturated fats (butter, fatty red meats, tropical plant oils, fast foods) and trans fat; choose fat-free or low-fat dairy products
Protein Consume protein in foods with low saturated fats (fish, egg whites, beans); there is no need to avoid animal proteinAvoid or limit processed meats
Micronutrients
Routine supplementation is not necessary; a healthful eating meal plan can generally provide sufficient micronutrientsChromium; vanadium; magnesium; vitamins A, C, and E; and CoQ10 are not recommended for glycemic controlVitamin supplements should be recommended to patients at risk of insufficiency or deficiency
Q4. How are glycemic targets achieved for T2D?
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE.
Noninsulin Agents Available for T2DClass Primary Mechanism of Action Agent(s) Available as-Glucosidase inhibitors
Delay carbohydrate absorption from intestine
AcarboseMiglitol
Precose or genericGlyset
Amylin analogue Decrease glucagon secretion Slow gastric emptying Increase satiety
Pramlintide Symlin
Biguanide Decrease HGP Increase glucose uptake in
muscleMetformin Glucophage or
generic
Bile acid sequestrant
Decrease HGP? Increase incretin levels?
Colesevelam WelChol
DPP-4 inhibitors Increase glucose-dependent
insulin secretion Decrease glucagon secretion
AlogliptinLinagliptinSaxagliptinSitagliptin
NesinaTradjentaOnglyzaJanuvia
Dopamine-2 agonist
Activates dopaminergic receptors
Bromocriptine Cycloset
Glinides Increase insulin secretion NateglinideRepaglinide
Starlix or genericPrandin
22
DPP-4 = dipeptidyl peptidase; HGP = hepatic glucose production.
Garber AJ, et al. Endocr Pract. 2013;19(suppl 2):1-48. Inzucchi SE, et al. Diabetes Care. 2012;35:1364-1379.
Q4. How are glycemic targets achieved for T2D?
Continued on next slide
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Noninsulin Agents Available for T2DClass Primary Mechanism of Action Agent(s) Available as
GLP-1 receptor agonists
Increase glucose-dependent insulin secretion
Decrease glucagon secretion Slow gastric emptying Increase satiety
AlbiglutideDulaglutideExenatideExenatide XRLiraglutide
TanzeumTrulicityByettaBydureonVictoza
SGLT2 inhibitors Increase urinary excretion of glucose
CanagliflozinDapagliflozinEmpagliflozin
InvokanaFarxigaJardiance
Sulfonylureas Increase insulin secretion
GlimepirideGlipizideGlyburide
Amaryl or genericGlucotrol or genericDiaeta, Glynase, Micronase, or generic
Thiazolidinediones
Increase glucose uptake in muscle and fat
Decrease HGP
PioglitazoneRosiglitazone
ActosAvandia
23
Q4. How are glycemic targets achieved for T2D?
GLP-1 = glucagon-like peptide; HGP = hepatic glucose production; SGLT2 = sodium glucose cotransporter 2.
Garber AJ, et al. Endocr Pract. 2013;19(suppl 2):1-48. Inzucchi SE, et al. Diabetes Care. 2012;35:1364-1379.
Continued from previous slide
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Effects of Agents Available for T2D
24
Q4. How are glycemic targets achieved for T2D?
AGI = -glucosidase inhibitors; BCR-QR = bromocriptine quick release; Coles = colesevelam; DPP4I = dipeptidyl peptidase 4 inhibitors; FPG = fasting plasma glucose; GLP1RA = glucagon-like peptide 1 receptor agonists; Met = metformin; Mod = moderate; PPG = postprandial glucose; SGLT2I = sodium-glucose cotransporter 2 inhibitors; SU = sulfonylureas; TZD = thiazolidinediones.
*Mild: albiglutide and exenatide; moderate: dulaglutide, exenatide extended release, and liraglutide.
Met GLP1RA SGLT2I DPP4I TZD AGI Coles BCR-
QRSU/
Glinide Insulin Pram
FPG lowering
Mod Mild to mod* Mod Mild Mod Neutral Mild Neutral
SU: modGlinide:
mild
Mod to marked (basal insulin
or premixe
d)
Mild
PPG lowering
Mild Mod to marked Mild Mod Mild Mod Mild Mild Mod
Mod to marked (short/ rapid-acting insulin
or premixe
d)
Mod to marked
Continued on next slide
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Effects of Agents Available for T2D
25
Q4. How are glycemic targets achieved for T2D?
AGI = -glucosidase inhibitors; BCR-QR = bromocriptine quick release; Coles = colesevelam; DPP4I = dipeptidyl peptidase 4 inhibitors; GLP1RA = glucagon-like peptide 1 receptor agonists; Met = metformin; Mod = moderate; NAFLD, nonalcoholic fatty liver disease; SGLT2I = sodium-glucose cotransporter 2 inhibitors; SU = sulfonylureas; TZD = thiazolidinediones.
*Especially with short/ rapid-acting or premixed.
Met GLP1RA SGLT2I DPP4I TZD AGI Coles BCR-
QRSU/
Glinide Insulin Pram
NAFLD benefit Mild Mild Neutral Neutral Mod Neutral Neutral Neutral Neutral Neutral Neutral
Hypo-glycemia Neutral Neutral Neutral Neutral Neutral Neutral Neutral Neutral
SU: mod to
severeGlinide: mild to
mod
Mod to severe* Neutral
Weight Slight loss Loss Loss Neutral Gain Neutral Neutral Neutral Gain Gain Loss
Continued from previous slide
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Effects of Agents Available for T2D
26
Q4. How are glycemic targets achieved for T2D?
Met GLP1RA SGLT2I DPP4I TZD AGI Coles BCR-
QRSU/
Glinide Insulin Pram
Renal impair-ment/ GU
Contra-indicate
d in stage
3B, 4, 5 CKD
Exenatide
contra-indicated CrCl <30
mg/mL
GU infection risk
Dose adjust-ment
(except lina-
gliptin)
May worsen
fluid retentio
n
Neutral Neutral NeutralIncreased hypo-glycemia risk
Increased risks
of hypo-glycemia and fluid
retention
Neutral
GI adverse effects Mod Mod* Neutral Neutral
* Neutral Mod Mild Mod Neutral Neutral Mod
CHF Neutral Neutral Neutral Neutral† Mod Neutral Neutral Neutral Neutral Neutral Neutral
CVD Possible benefit Neutral Neutral Neutral Neutral Neutral Neutral Safe ? Neutral Neutral
Bone Neutral Neutral Bone loss Neutral
Mod bone loss
Neutral Neutral Neutral Neutral Neutral Neutral
Continued from previous slide
AGI = -glucosidase inhibitors; BCR-QR = bromocriptine quick release; Coles = colesevelam; CHF = congestive heart failure; CVD = cardiovascular disease; DPP4I = dipeptidyl peptidase 4 inhibitors; GI = gastrointestinal; GLP1RA = glucagon-like peptide 1 receptor agonists; GU = genitourinary; Met = metformin; Mod = moderate; SGLT2I = sodium-glucose cotransporter 2 inhibitors; SU = sulfonylureas; TZD = thiazolidinediones.
*Caution in labeling about pancreatitis.†Caution: possibly increased CHF hospitalization risk seen in CV safety trial.
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Monotherapy, Dual Therapy, and Triple Therapy for T2D
27
Q4. How are glycemic targets achieved for T2D?
AGI = -glucosidase inhibitors; BCR-QR = bromocriptine quick release; Coles = colesevelam; DPP4I = dipeptidyl peptidase 4 inhibitors; GLP1RA = glucagon-like peptide 1 receptor agonists; Met = metformin; SGLT2I = sodium-glucose cotransporter 2 inhibitors; SU = sulfonylureas; TZD = thiazolidinediones.
*Intensify therapy whenever A1C exceeds individualized target. Boldface denotes little or no risk of hypoglycemia or weight gain, few adverse events, and/or the possibility of benefits beyond glucose-lowering.† Use with caution.
Monotherapy* Dual therapy*
Metformin (or other first-line
agent) plus
Triple therapy*
First- and second-line agent plus
Metformin GLP1RA GLP1RAGLP1RA SGLT2I SGLT2ISGLT2I DPP4I TZD†
DPP4I TZD† Basal insulin†
AGI Basal insulin† DPP4ITZD† Colesevelam Colesevelam
SU/glinide† BCR-QR BCR-QR AGI AGI SU/glinide† SU/glinide†
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Insulin RegimensInsulin is required for survival in T1DPhysiologic regimens using insulin analogs
should be used for most patients
Q5. How should glycemia in T1D be managed?
Multiple daily injections (MDI)
•1-2 injections basal insulin per day•Prandial insulin injections before each meal
Continuous subcutaneous insulin
infusion (CSII)
•Insulin pump using rapid acting insulin analog
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Pharmacokinetics of InsulinAgent Onset
(h) Peak (h) Duration (h) Considerations
Basal
NPH 2-4 4-10 10-16 Greater risk of nocturnal hypoglycemia compared to insulin analogs
GlargineDetemir
~1-4 No pronounced peak*
Up to 24† Less nocturnal hypoglycemia compared to NPH
Basal-
Prandial
Regular U-500
≤0.5 ~2-3 12-24 Inject 30 min before a meal Indicated for highly insulin resistant
individuals Use caution when measuring dosage to
avoid inadvertent overdose
Prandial
Regular ~0.5-1 ~2-3 Up to 8 Must be injected 30-45 min before a meal
Injection with or after a meal could increase risk for hypoglycemia
AspartGlulisineLisproInhaled insulin
<0.5 ~0.5-2.5 ~3-5 Can be administered 0-15 min before a meal
Less risk of postprandial hypoglycemia compared to regular insulin
* Exhibits a peak at higher dosages.† Dose-dependent.NPH, Neutral Protamine Hagedorn.Moghissi E et al. Endocr Pract. 2013;19:526-535. Humulin R U-500 (concentrated) insulin prescribing information. Indianapolis: Lilly USA, LLC.
Q5. How should glycemia in T1D be managed?
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Principles of Insulin Therapy in T1DStarting dose based on weight
Range: 0.4-0.5 units/kg per dayDaily dosing
Basal 40% to 50% TDI Given as single injection of basal analog or 2 injections of NPH
per dayPrandial
50% to 60% of TDI in divided doses given 15 min before each meal
Each dose determined by estimating carbohydrate content of meal
Higher TDI needed for obese patients, those with sedentary lifestyles, and during puberty
Q5. How should glycemia in T1D be managed?
TDI = total daily insulin.
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Consequences of HypoglycemiaCognitive, psychological changes (eg, confusion,
irritability)AccidentsFallsRecurrent hypoglycemia and hypoglycemia unawarenessRefractory diabetesDementia (elderly)CV events
Cardiac autonomic neuropathyCardiac ischemiaAnginaFatal arrhythmia
Q6. How should hypoglycemia be managed?
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Symptoms of HypoglycemiaClassification
Blood Glucose Level
(mg/dL)Typical Signs and Symptoms
Mild hypoglycemia ~50-70 • Neurogenic: palpitations, tremor, hunger, sweating, anxiety, paresthesia
Moderate hypoglycemia ~50-70
• Neuroglycopenic: behavioral changes, emotional lability, difficulty thinking, confusion
Severe hypoglycemia <50*• Severe confusion, unconsciousness,
seizure, coma, death• Requires help from another individual
*Severe hypoglycemia symptoms should be treated regardless of blood glucose level.
Q6. How should hypoglycemia be managed?
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Treatment of Hypoglycemia
Q6. How should hypoglycemia be managed?
Patient severely confused or unconscious (requires
help)
• Consume glucose-containing foods (fruit juice, soft drink, crackers, milk, glucose tablets); avoid foods also containing fat
• Repeat glucose intake if SMBG result remains low after 15 minutes
• Consume meal or snack after SMBG has returned to normal to avoid recurrence
Patient conscious and alert
Hypoglycemia symptoms(BG <70 mg/dL)
• Glucagon injection, delivered by another person
• Patient should be taken to hospital for evaluation and treatment after any severe episode
BG = blood glucose; SMBG = self-monitoring of blood glucose.
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Blood Pressure Targets
Q7. How should hypertension be managed?
Parameter Treatment Goal
Blood pressureIndividualize on the basis of age, comorbidities, and duration of disease, with general target of:
Systolic, mm Hg ~130
Diastolic, mm Hg ~80 A more intensive goal (such as <120/80 mm Hg) should be
considered for some patients, provided the target can be safely reached without adverse effects from medication.
More relaxed goals may be considered for patients with complicated comorbidities or those experience adverse medication effects.
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Blood Pressure TreatmentEmploy therapeutic lifestyle modification
DASH or other low-salt diet Physical activity
Select antihypertensive medications based on BP-lowering effects and ability to slow progression of nephropathy and retinopathy ACE inhibitorsor ARBs
Add additional agents when needed to achieve blood pressure targets Calcium channel antagonists Diuretics Combined /-adrenergic blockers -adrenergic blockers Do not combine ACE inhibitors with ARBs
Q7. How should hypertension be managed?
ACE = angiotensin converting enzyme; ARB = angiotensin II receptor blocker; BP = blood pressure; DASH = Dietary Approaches to Stop Hypertension.
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Lipid Targets
Q8. How should dyslipidemia be managed?
Parameter Treatment GoalModerate risk High risk
Primary GoalsLDL-C, mg/dL <100 <70Non–HDL-C, mg/dL <130 <100Triglycerides, mg/dL <150 <150TC/HDL-C ratio <3.5 <3.0
Secondary GoalsApoB, mg/dL <90 <80LDL particles <1,200 <1,000
ApoB = apolipoprotein B; ASCVD = atherosclerotic cardiovascular disease; CV = cardiovascular; HDL-C = high density lipoprotein cholesterol; LDL = low-density lipoprotein; LDL-C = low-density lipoprotein cholesterol; TC = total cholesterol.
Moderate risk = diabetes or prediabetes with no ASCVD or major CV risk factors High risk = established ASCVD or ≥1 major CV risk factor CV risk factors
Hypertension Family history
Low HDL-C Smoking
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Lipid ManagementElevated LDL-C, non-HDL-C, TG, TC/HDL-C
ratio, ApoB, LDL particles
•Statin = treatment of choice•Add bile acid sequestrant, niacin, and/or cholesterol absorption inhibitor if target not met on maximum-tolerated dose of statin•Use bile acid sequestrant, niacin, or cholesterol absorption inhibitor instead of statin if contraindicated or not tolerated
LDL-C at goal but non-HDL-C not at goal(TG ≥200 mg/dL
and/or low HDL-C)
•May use fibrate, niacin, or high-dose omega-3 fatty acid to achieve non-HDL-C goal
TG ≥500 mg/dL
•Use high-dose omega-3 fatty acid, fibrate, or niacin to reduce TG and risk of pancreatitis
Q8. How should dyslipidemia be managed?
ApoB = apolipoprotein B; HDL-C = high density lipoprotein cholesterol; LDL = low-density lipoprotein; LDL-C = low-density lipoprotein cholesterol; TC = total cholesterol; TG = triglycerides.
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Assessment of Diabetic Nephropathy
Q9. How is nephropathy managed in patients with diabetes?
AER = albumin excretion rate; eGFR = estimated glomerular filtration rate; T1D = type 1 diabetes; T2D = type 2 diabetes.
Annual assessmentsSerum creatinine to determine eGFRUrine AER
Begin annual screening5 years after diagnosis of T1D if diagnosed
before age 30 yearsAt diagnosis of T2D or T1D in patients
diagnosed after age 30 years
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Staging of Chronic Kidney Disease
Q9. How is nephropathy managed in patients with diabetes?
CKD = chronic kidney disease; GFR = glomerular filtration rate; NKF = National Kidney Foundation.Levey AS, et al. Kidney Int. 2011;80:17-28.
Persistent albuminuria categoriesDescription and range
Previous NKF CKD stage
Guide to frequency of monitoring (number of times per year) by GFR and albuminuria category
A1 A2 A3
Normal to mildly
increasedModerately increased
Severely increased
<30 mg/g<3 mg/mmol
30-300 mg/g3-30
mg/mmol
>300 mg/g>30
mg/mmol
GFR categories
(mL/min/1.73 m2)Description and rang
e
1 G1 Normal or high ≥90 1 if CKD 1 2
2 G2 Mildly decreased 60-89 1 if CKD 1 2
3
G3aMild to
moderately decreased
45-59 1 2 3
G3bModerately to
severely decreased
30-44 2 3 3
4 G4 Severely decreased 15-29 3 3 4+
5 G5 Kidney failure <15 4+ 4+ 4+
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Management of Diabetic NephropathyOptimal control of blood pressure, glucose, and
lipidsSmoking cessationRAAS blockade
ACE inhibitor, ARB, or renin inhibitorDo not combine RAAS blocking agentsMonitor serum potassium
Nephrologist referralAtypical presentationRapid decline in eGFR or albuminuria progressionStage 4 CKD
Q9. How is nephropathy managed in patients with diabetes?
ACE = angiotensin converting enzyme; ARB = angiotensin II receptor blocker; CKD = chronic kidney disease; eGFR = estimated glomerular filtration rate; RAAS = renin angiotensin aldosterone system.
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Assessment of Diabetic Retinopathy
Q10. How is retinopathy managed in patients with diabetes?
DM = diabetes mellitus; T1D = type 1 diabetes; T2D = type 2 diabetes.
Annual dilated eye examination by experienced ophthalmologist or optometrist
Begin assessment5 years after diagnosis of T1DAt diagnosis of T2D
More frequent examinations for:Pregnant women with DM during pregnancy
and 1 year postpartumPatients with diagnosed retinopathyPatients with macular edema receiving active
therapy
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Management of Diabetic Retinopathy
Q10. How is retinopathy managed in patients with diabetes?
DM = diabetes mellitus; T1D = type 1 diabetes; T2D = type 2 diabetes.
Slow retinopathy progression by maintaining optimal control ofBlood glucoseBlood pressureLipids
For active retinopathy, refer to ophthalmologist as neededFor laser therapyFor vascular endothelial growth factor therapy
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Assessment of Diabetic NeuropathyComplete neurologic examination annuallyBegin assessment
5 years after diagnosis of T1DAt diagnosis of T2D
Q11. How is neuropathy diagnosed and managed in patients with diabetes?
T1D = type 1 diabetes; T2D = type 2 diabetes.
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Diabetic Neuropathy Evaluations and TestsFoot inspection Foot structure and deformities
Skin temperature and integrityUlcersVascular statusPedal pulsesAmputations
Neurologic testing Loss of sensation, using 1 and 10-g monofilamentVibration perception using 128-Hz tuning forkAnkle reflexesTouch, pinprick, and warm and cold sensation
Painful neuropathy May have no physical signsDiagnosis may require skin biopsy or other surrogate measure
Cardiovascular autonomic neuropathy
Heart rate variability with:• Deep inspiration• Valsalva maneuver• Change in position from prone to standing
Q11. How is neuropathy diagnosed and managed in patients with diabetes?
DM = diabetes mellitus; T1D = type 1 diabetes; T2D = type 2 diabetes.
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 48
Diabetic Neuropathy ManagementAll neuropathies • Prevent by controlling blood glucose to individual
targets• No therapies proven to reverse neuropathy once it is
established• May slow progression by maintaining optimal glucose,
blood pressure, and lipid control and using other interventions that reduce oxidative stress
Painful neuropathy
• Tricyclic antidepressants, anticonvulsants, serotonin reuptake inhibitors, or norepinephrine reuptake inhibitors
Large-fiber neuropathies
• Strength, gait, and balance training• Orthotics to prevent/treat foot deformities• Tendon lengthening for pes equinus• Surgical reconstruction• Casting
Small-fiber neuropathies
• Foot protection (eg, padded socks)• Supportive shoes with orthotics if needed• Regular foot inspection• Prevention of heat injury• Emollient creams
Q11. How is neuropathy diagnosed and managed in patients with diabetes?
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Comprehensive Management of CV RiskManage CV risk factors
Weight lossSmoking cessationOptimal glucose, blood pressure, and lipid control
Use low-dose aspirin for secondary prevention of CV events in patients with existing CVDMay consider low-dose aspirin for primary prevention
of CV events in patients with 10-year CV risk >10%Measure coronary artery calcification or use
coronary imaging to determine whether glucose, lipid, or blood pressure control efforts should be intensified
Q12. How is CVD managed in patients with diabetes?
CV = cardiovascular; CVD = cardiovascular disease.
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Statin UseMajority of patients
with T2D have a high cardiovascular risk
People with T1D are at elevated cardiovascular risk
LDL-C target: <70 mg/dL—for the majority of patients with diabetes who are determined to have a high risk
Use a statin regardless of LDL-C level in patients with diabetes who meet the following criteria:>40 years of age≥1 major ASCVD risk
factor Hypertension Family history of CVD Low HDL-C Smoking
Q12. How is CVD managed in patients with diabetes?
ASCVD = atherosclerotic cardiovascular disease; CVD = cardiovascular disease; HDL-C = high density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol.
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Diagnosis of Obesity and Staging of for ManagementDiagnose obesity according to body mass index (BMI)
Overweight: BMI 25-29.9 kg/m2
Obese*: BMI ≥30 kg/m2
Consider waist circumference measurement for patients with BMI between 25 and 35 kg/m2
Larger waist circumference = higher risk for metabolic disease Men: >102 cm (40 in) Women: >88 cm (35 in)
Evaluate patients for obesity-related complications to determine disease severity and appropriate management
Q13. How is obesity managed in patients with diabetes?
51
*BMI 23-24.9 may be considered obese in certain ethnicities; perform waist circumference and use ethnicity-specific criteria in risk analysis.
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Medical Complications of Obesity
NAFLD
Cardiovascular Disease
Dismotility/disability
GERDLung function
defectsOsteoarthritisSleep apnea
Urinaryincontinence
Prediabetic states
HypertensionDyslipidemia
PCOS
Diabetes
CardiometabolicBiomechanical
Other
GERD, gastroesophageal reflux disease; NAFLD, nonalcoholic fatty liver disease; PCOS, polycystic ovary syndrome.
Pi-Sunyer X. Postgrad Med. 2009;121:21-33.
Androgen deficiency
CancerGallbladder
diseasePsychologica
ldisorders
Obesity
Q13. How is obesity managed in patients with diabetes?
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Obstructive Sleep ApneaRisk Factors Treatment Options
ObesityMale sexNeck circumference >44
cmAgeNarrowed airwayFamily historyHypertensionAlcohol or sedativesSmoking
Weight lossContinuous positive airway
pressure (CPAP)Additional options
Adjustable airway pressure devices
Oral appliances Surgery
Uvulopalatopharyngoplasty (UPPP)
Maxillomandibular advancement
Tracheostomy
Q14. What is the role of sleep medicine in the care of the patient with diabetes?
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Glucose Screening and MonitoringLaboratory blood glucose testing on admission,
regardless of DM historyKnown DM: assess A1C if not measured in past 3
monthsNo history of DM: assess A1C to identify undiagnosed
casesBedside glucose monitoring for duration of hospital
stayDiagnosed DMNo DM but receiving therapy associated with
hyperglycemia Corticosteroids Enteral or parenteral nutrition
Q15. How is diabetes managed in the hospital?
DM = diabetes mellitus.
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Inpatient Glucose Targets for Nonpregnant Adults
Hospital Unit Treatment GoalIntensive/critical care
Glucose range, mg/dL 140-180*
General medicine and surgery, non-ICU
Premeal glucose, mg/dL <140*Random glucose, mg/dL <180*
ICU = intensive care unit.
*Provided target can be safely achieved.
Q15. How is diabetes managed in the hospital?
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Glucose ControlHyperglycemia Hypoglycemia
Critically ill/ICU patients Regular insulin by
intravenous infusionNoncritically ill
Insulin analogs by scheduled subcutaneous basal, nutritional, and correctional components
Synchronize dosing with meals or enteral or parenteral nutrition
Exclusive use of sliding scale insulin is discouraged
Establish plan for treating hypoglycemia in each insulin-treated patient
Document each episode of hypoglycemia in medical record
Q15. How is diabetes managed in the hospital?
ICU = intensive care unit.
Discharge PlansInclude appropriate
provisions for glucose control in the outpatient setting
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Annual Incidence of DM in Youth
AI = American Indians; API = Asians/Pacific Islanders; DM = diabetes mellitus; H = Hispanics; NHB = non-Hispanic blacks;NHW = non-Hispanic whites.
CDC. National diabetes statistics report, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.
<10 years 10-19 years
All NHW
NHB
H API AIAN*
All NHW
NHB
H API AIAN*
0
10
20
30
40
50
Type 1 Type 2
Rat
e (p
er 1
00,0
00 p
er
year
)
Q16. How is a comprehensive care plan established in children and adolescents?
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Management of DMT1D T2D
Use MDI or CSII insulin In children younger than 4
years, bolus insulin may be given after, rather than before, meals due to variable carbohydrate intake
Higher insulin-to-carbohydrate ratios may be needed during puberty
Pubescent girls may require 20% to 50% increases in insulin dose during menstrual periods
Lifestyle modification is first-line therapy
Metformin, alone or in combination with insulin, is approved by the FDA to treat T2D in pediatric patients
Rosiglitazone and glimepiride have also been studied in pediatric patients with T2D
Q16. How is a comprehensive care plan established in children and adolescents?
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Outpatient Glucose Targets for Pregnant Women
Condition Treatment GoalGestational diabetes mellitus (GDM)
Preprandial glucose, mg/dL ≤95*
1-Hour PPG, mg/dL ≤140*
2-Hour PPG, mg/dL ≤120*
Preexisting T1D or T2DPremeal, bedtime, and overnight glucose, mg/dL 60-99*
Peak PPG, mg/dL 100-129*
A1C ≤6.0%*
FPG = fasting plasma glucose; PPG = postprandial glucose.
*Provided target can be safely achieved.
Q17. How should diabetes in pregnancy be managed?
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Treatment of DM During PregnancyAll women with T1D, T2D, or previous GDM
should receive preconception care to ensure adequate nutrition and glucose control before conception, during pregnancy, and in the postpartum period
Use insulin to treat hyperglycemia in T1D and T2D and when lifestyle measures do not control glycemia in GDMBasal insulin: NPH or insulin detemirPrandial insulin: insulin analogs preferred, but
regular insulin acceptable if analogs not available
Q17. How should diabetes in pregnancy be managed?
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Self-monitoring of Blood Glucose (SMBG)
SMBG, self-monitoring of blood glucose.
Q18. When and how should glucose monitoring be used?
Noninsulin Users Insulin Users Introduce at diagnosisPersonalize frequency of
testingUse SMBG results to
inform decisions about whether to target FPG or PPG for any individual patient
All patients using insulin should test glucose ≥2 times daily Before any injection of
insulinMore frequent SMBG
(after meals or in the middle of the night) may be required Frequent hypoglycemia Not at A1C target
Testing positively affects glycemia in T2D when the results are used to:• Modify behavior• Modify pharmacologic
treatment
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SMBG Frequency vs A1C
Q18. When and how should glucose monitoring be used?
Miller KM, et al. Diabetes Care. 2013;36:2009-2014.
1-13 years13-26 years
26-50 years50+ years
SMBG per day0-2 3-4 5-6 7-8 9-
1011-12
≥136.57.07.58.08.59.09.510.
0
10.5
11.0
Mea
n A
1C
Copyright © 2015 AACE. May not be reprinted in any form without express written permission from AACE. 64
Continuous Glucose Monitoring (CGM)Uses Limitations
Consider for T1D patients (and insulin-using T2D patients) to improve A1C and reduce hypoglycemia
Features “Real-time” glucose values
(but 7- to 15-minute lag between plasma and interstitial glucose and receiver display)
Hypo- and hyperglycemia alarms
Wireless interfaces with downloadable/printable data
Invasive (worn like a pump)
Requires daily calibration with fingerstick SMBG
Lengthy data download time
Requires highly motivated/informed patients and healthcare support teamMust be able to
interpret data trends rather than data points
Hirsch IB. J Clin Endocrinol Metab. 2009;94:2232-2238.
Q18. When and how should glucose monitoring be used?
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Continuous Subcutaneous Insulin Infusion (CSII)Consider for
T1D patientsInsulinopenic T2D patients unable to achieve
optimal glucose control with multiple daily injections of insulin
All patients should be motivated and well educated in DM self-management as well as CSII use
Prescribing physicians should have expertise in CSII
CSII devices with a threshold-suspend function may be considered
Q19. When and how should insulin pump therapy be used?
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CSII Meta-Analyses in T1D and T2DReference Findings
Weissberg-Benchell et al, Diabetes Care. 2003;26(4):1079-
1087 Compared with MDI, CSII therapy was associated with significant improvements in glycemic control based on HbA1c and mean blood glucose decreases
Jeitler et al, Diabetologia. 2008;51(6):941-951
HbA1c reduction greater and insulin requirements lower with CSII than with MDI in adults and adolescents with T1DM; hypoglycemia risk comparable among adult patients (data unavailable for adolescent subjects); no conclusive CSII benefits for patients with T2DM
Fatourechi et al,J Clin Endocrinol Metab.
2009;94(3):729-740 In patients with T1DM, HbA1c was mildly decreased with CSII vs. MDI; CSII effect on hypoglycemia unclear; similar CSII and MDI outcomes among patients with T2DM
Pickup & Sutton, Diabet Med. 2008;25(7):765-774
HbA1c was lower for CSII than for MDI, with greatest improvement in patients with highest initial HbA1c values on MDI; severe hypoglycemia risk was decreased with CSII vs. MDI; greatest reduction in patients with diabetes of longest duration and/or highest baseline rates of severe hypoglycemia
Monami et al,Exp Clin Endocrinol Diabetes.
2009;117(5):220-222
HbA1c was significantly lower with CSII vs. MDI; HbA1c reduction was only evident for studies with mean patient age >10 years; severe hypoglycemia occurred at comparable rates with CSII and MDI therapy
CSII, continuous subcutaneous insulin infusion; DKA, diabetic ketoacidosis; HbA1c, hemoglobin A1c; MDI, multiple daily injections; RCT, randomized controlled trial; T1DM, type 1 diabetes mellitus; T2D, type 2 diabetes.
Q19. When and how should insulin pump therapy be used?
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CSII Randomized, Controlled Trials in T2DA1C (%)
Reference Design Baseline CSII MDI P value
Noh et al, Diabetes Metab Res Rev. 2008;24(5):384-391.
30-week observational study (N=15)
7.9 5.0 NA <0.001
Parkner et al, Diabetes Obes Metab. 2008;10(7):556-563.
Observational study, 3 successive nights (N=10)
Fasting plasma glucose: 209 mg/dL
99.1 mg/dL
NA <0.0001
Berthe et al, Horm Metab Res. 2007;39(3):224-229.
Crossover study, 2 12-week periods (N=17)
9.0 7.7 8.6 <0.03
Herman et al, Diabetes Care. 2005;28(7):1568-1573.
1 year parallel study (N=107) CSII: 8.4 MDI: 8.1
6.6 6.4 0.19
Raskin et al, Diabetes Care. 2003;26(9):2598-2603
24 week parallel study (N=132)
CSII: 8.2 MDI: 8.0
7.6 7.5 NS
Wainstein et al, Diabet Med. 2005;22(8):1037-1046.
Crossover study, 2 18-week periods (N=40)
CSII-MDI: 10.1 MDI-CSII 10.2
−0.8 +0.4 0.007
CSII: continuous subcutaneous insulin infusion; MDI: multiple daily injection; T2DM: type 2 diabetes.
Q19. When and how should insulin pump therapy be used?
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DM Comprehensive Management Team
Q20. What is the imperative for education and team approach in DM management?
Patient
Endocrin-ologist
PCP
Physician assistant / Nurse practi-tioner
Registered nurse
CDE
Dietitian
Exercise specialist
Mental health care
profes-sional
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Vaccinations for Patients with DMVaccine, frequency of administration Patient ageRoutine childhood immunizations, according to standard schedule (eg, measles, mumps, rubella, varicella, polio, tetanus-diphtheria)
6 months to 18 years
Influenza, annually ≥6 months
Pneumococcal polysaccharide vaccine ≥2 years
PVC13, 1-2 injections 2-18 years
PPSV23, 1 injection 19-64 years
PVC13 plus PPSV23,1 injection each, in series ≥65 years
Hepatitis B, 1 injection 20-59 years*
Tetanus-diphtheria booster, every 10 years in adults ≥19 years
Individuals not already immunized for childhood diseases and those requiring vaccines for endemic diseases should be immunized as required by individual patient needs
Any age
*Consider for patients ≥60 based on assessment of risk and likelihood of adequate immune response.
Q21. What vaccinations should be given to patients with diabetes?
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DM and Depression
Q22. How should depression be managed in the context of diabetes?
Screen all adults with DM for depressionUntreated comorbid depression can have
serious clinical implications for patients with DM
Consider referring patients with depression to mental health professionals who are knowledgeable about DM
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DM and CancerScreen obese individuals with DM more frequently and
rigorously for certain cancersEndometrial, breast, hepatic, bladder, pancreatic, colorectal
cancersIncreased BMI (≥25 kg/m2) also increases risk of some cancers
Strong associations: endometrial, gall bladder, esophageal , renal, thyroid, ovarian, breast, and colorectal cancer
Weaker associations: leukemia, malignant and multiple melanoma, pancreatic cancer, non-Hodgkin lymphoma
To date, no definitive relationship has been established between specific hyperglycemic agents and increased risk of cancer or cancer-related mortalityConsider avoiding medications considered disadvantageous to
specific cancers in individuals at risk for or with a history of that cancer
Q23. What is the association between diabetes and cancer?
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DM and Occupational Hazards
Q24. Which occupations have specific diabetes management requirements?
Commercial drivers at high risk for developing T2DScreen as appropriateEncourage healthy lifestyle change
Be aware of management requirements and use agents with reduced risk of hypoglycemia in patients with occupations that could put others at risk, such as (not inclusive):Commercial driversPilotsAnesthesiologistsCommercial or recreational divers
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